Do you still have questions about Pulmozyme?

About Pulmozyme

Should I continue using Pulmozyme even when I can’t feel it?

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It is important to take Pulmozyme as your doctor has prescribed.
Pulmozyme has a distinct role in the fight against cystic fibrosis.
One of the causes of thickened mucus in the lungs is extracellular
DNA. As seen in laboratory studies, Pulmozyme uniquely cuts apart
extracellular DNA by acting like an enzyme naturally found in the
lungs. Cutting up extracellular DNA can help make mucus thinner and
looser, which can make it easier to clear your lungs. In a clinical
study of patients 5 years of age or older with a forced vital capacity
(FVC) greater than or equal to 40% of predicted, Pulmozyme, when taken
once-daily or twice-daily, was shown to improve lung function. If you
have questions about the importance of taking Pulmozyme, talk to your doctor.

Why would my doctor still prescribe Pulmozyme if I am on a
gene-specific cystic fibrosis treatment?

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Every prescribed therapy plays a role to help you fight cystic fibrosis.

Pulmozyme is a mucolytic. In laboratory studies, Pulmozyme was shown
to act like a protein already in your body to cut apart the sticky
mucus your lungs produce, making it thinner and looser.

Gene-specific treatments, also called cystic fibrosis transmembrane
conductance regulator (CFTR) modulators, were studied for use in
patients with specific genetic mutations. Even though studies for
these gene-specific treatments were not designed to look at the
efficacy and safety of CFTR modulators in combination with existing
treatments, patients in these studies stayed on their prescribed
cystic fibrosis therapies (eg, Pulmozyme, tobramycin).

Pulmozyme was approved by the US Food and Drug Administration (FDA)
in 1993, and was the first drug developed specifically for cystic fibrosis.

Patients may experience the following when using Pulmozyme: change
in or loss of voice, throat discomfort, rash, chest pain, red watery
eyes, runny nose, lowering of lung function, fever, indigestion, and
shortness of breath. There have been no reports of severe allergic
reactions caused by the administration of Pulmozyme. Mild to moderate
hives and mild skin rash have been observed and have been short-lived.

Pulmozyme is to be used with other standard cystic fibrosis
treatments and has demonstrated safety in children 5 years of age or
older, adolescents, and adults. The efficacy of Pulmozyme has not been
studied in patients less than 5 years of age. The safety of Pulmozyme,
2.5 mg by inhalation, was studied with 2 weeks of daily administration
in 65 patients with cystic fibrosis aged 3 months to < 5 years.
Overall, the nature of adverse events was similar to that seen in the
placebo-controlled trials in older patients. The number of patients
reporting cough was higher in the younger age group as compared to the
older age group (45%; compared to 30%) as was the number reporting
moderate to severe cough (37%; compared to 18%). The number of
patients reporting rhinitis was higher in the younger age group as
compared to the older age group (35%; compared to 27%) as was the
number reporting rash (6% as compared to 0%).

Pulmozyme should not be used in patients who are allergic to any of
its ingredients.

You should call your doctor if you experience any of these side
effects or if any of these side effects are severe, get worse, or do
not go away.

What are the possible side effects of Pulmozyme?

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You may feel more prepared if you talk to your doctor about what to
expect before you begin Pulmozyme. Based on studies, patients taking
Pulmozyme may experience change in or loss of their voice, discomfort
in the throat, rash, chest pain, red watery eyes, runny nose, lowering
of lung function, fever, indigestion, and shortness of breath. Mild to
moderate hives and mild skin rash have been observed and have been
short-lived. You should call your doctor if you experience any of
these side effects or if any of these side effects are severe, get
worse, or do not go away.

These are not all the possible side effects of Pulmozyme. Please see
the full Pulmozyme Prescribing Information for additional Important
Safety Information.

Is Pulmozyme right for me?

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Pulmozyme may be an essential partner in your fight against cystic
fibrosis. In cystic fibrosis, your lungs produce extra-thick, sticky
mucus. Laboratory studies have shown that Pulmozyme makes mucus
thinner and looser. See
the clinical data and learn more about whether Pulmozyme is
right for you.

Which Pulmozyme dose is right for me?

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The recommended dose for most cystic fibrosis patients is Pulmozyme
2.5 mg once-daily.

Some patients over 21 may benefit from twice-daily treatment. You
should ask your doctor whether prescribing Pulmozyme 2.5 mg
twice-daily may be right for you.

Taking Pulmozyme

Why is Pulmozyme an important part of my cystic fibrosis treatment regimen?

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Treating cystic fibrosis is complicated so it is important to take
all your treatments as prescribed by your doctor. As seen in
laboratory studies, Pulmozyme works to help make mucus thinner and
looser. Your doctor will prescribe other medicines to take in addition
to Pulmozyme. These other medicines may include:

Bronchodilators help open airways

Hydrators help
increase moisture in thick mucus

Airway clearance
techniques help physically loosen and move mucus out of the way

Antibiotics help prevent and treat infections

Gene-specific treatments, also known as cystic fibrosis
transmembrane conductance regulator (CFTR) modulators, help keep a
balance of salt and water in the lungs

What nebulizers can I use to take Pulmozyme?

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The FDA has approved specific nebulizers/compressors to be used with Pulmozyme.

One nebulizer system is FDA-approved:

eRapid® (PARI) Nebulizer System

The following nebulizers and compressors have been approved for use
with Pulmozyme:

Hudson T Up-draft II® with Pulmo-Aide®

Marquest Acorn II® with Pulmo-Aide®

PARI LC® PLUS with PARI PRONEB®

PARI BABY™ with PARI PRONEB®

Durable Sidestream® with MOBILAIRE™

Durable Sidestream® with Porta-Neb®

Please contact your doctor and/or CF Care Team for more information
about nebulizers and compressors, and for guidance in choosing
products that are right for you.

How do you use the Pulmozyme ampule?

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Pulmozyme comes in sterile, single-use ampules that should be used
completely. Because Pulmozyme has no preservatives, the entire
contents must be used or discarded.

It is important to store ampules of Pulmozyme in their protective
foil pouch under refrigeration and protected from light. Refrigerate
Pulmozyme during transport, and do not expose it to room temperatures
for more than 24 hours.

Each ampule should be squeezed prior to use in order to check for
leaks. Discard ampules if the solution is cloudy or discolored. Once
opened, the entire contents of the ampule must be used or discarded.

How can I fit my Pulmozyme treatment into my daily routine?

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Finding the time and place to take your treatments, like Pulmozyme,
isn’t always easy. No one is perfect. But having a routine that fits
your lifestyle can help you stay in control and assist in your fight
against cystic fibrosis.

Does Pulmozyme expire?

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There are expiration dates stamped on each ampule. It is important to
follow the stamped date and discard any ampules that expire.

How should I store Pulmozyme?

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Each sterile, single-use ampule of Pulmozyme (2.5 mg) is packaged in
a protective foil pouch. The ampules should be left in their foil
package and stored in the refrigerator. They should also be kept away
from strong light. Refrigerate Pulmozyme during transport, and do not
expose it to room temperatures for more than 24 hours.

Understanding cystic fibrosis

What is cystic fibrosis?

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Cystic fibrosis is a genetic condition, which means that it is
something you are born with. Cystic fibrosis is known to cause your
lungs to produce extra-thick, sticky mucus. This mucus builds up and
clogs your airways.

What makes healthy lungs "healthy"?

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The lungs naturally produce a thin layer of mucus that helps protect
the airways from dangerous bacteria that can cause infections.

How are lungs affected by cystic fibrosis different?

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For people living with cystic fibrosis, the mucus in the lungs is
thicker than normal, and becomes a source of inflammation and
infection that can lead to decreased lung function and exacerbation of infections.

Patient support

I’m worried about being able to afford Pulmozyme. Is there anything I
can do?

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Genentech Access Solutions may be able to help you understand how to
get the medicine you need.

If you are eligible, there may be options to help you pay for Pulmozyme*:

Important Safety Information & Indication

Indication and Usage

Pulmozyme (dornase alfa) is indicated for daily administration along with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.

In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring injectable antibiotics.

Important Safety Information

Pulmozyme should not be used in patients who are allergic to any of its ingredients.

Patients may experience the following when using Pulmozyme: change in or loss of their voice, discomfort in the throat, rash, chest pain, red watery eyes, runny nose, lowering of lung function, fever, indigestion, and shortness of breath. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Mild to moderate hives and mild skin rash have been observed and have been short-lived.

Pediatric Use

The safety and effectiveness of Pulmozyme have been established in patients 5 years of age and older. While clinical trial data are limited in patients younger than 5 years of age, the use of Pulmozyme should be considered for pediatric CF patients who may experience potential benefit in lung function or who may be at risk of respiratory tract infection.

The safety of Pulmozyme given by daily inhalation for 2 weeks has been studied using 98 CF patients with 65 of them aged 3 months to <5 years (younger group) and 33 aged 5 years to <10 years (older group). The PARI BABY™ reusable nebulizer (which uses a face mask instead of a mouthpiece) was used in patients who were unable to show that they could breathe in or out using their mouth throughout the entire treatment period. Overall, the kind of side effects observed in children was similar to those seen in larger trials in older patients.

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Pulmozyme Prescribing Information for additional Important Safety Information. If you have questions, please discuss them with your CF Care Team.

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